Spironolactone

Product NDC
63629-2438
11-digit product format
636292438
Labeler code
63629
Product ID
63629-2438_dca8fb3f-0258-4cc5-b4c6-4ac3bc31f1de
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
spironolactone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203253
Marketing category
ANDA
Marketing start
2013-02-01
Substance
SPIRONOLACTONE
Active strength
50 mg/1
Pharmacologic classes
Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Spironolactone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SPIRONOLACTONE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii27O7W4T232
Rxcui198223

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d335cba1-5b36-51c8-120a-594ec9d05330Product name520251114
25f5e2cf-3572-477b-994c-aa692751e5a8Product name220250616
f151007d-265d-9fbe-857d-1d44f1cb76baProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-2438-1Spironolactone100 in 1 BOTTLETABLET, FILM COATED100103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2438-1EA - Each63629-243873b7b485-64db-4cc9-a9bb-990e467736b712021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2438SPIRONOLACTONE (SPIRONOLACTONE) TABLET, FILM COATED [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 1 package rows20240817_9d747bf5-31aa-48a5-9c6d-3cf8ce99a8f1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198223spironolactone 50 MG Oral TabletPSN9d747bf5-31aa-48a5-9c6d-3cf8ce99a8f1103
198223spironolactone 50 MG Oral TabletSCD9d747bf5-31aa-48a5-9c6d-3cf8ce99a8f1103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-2438-163629243801100 TABLET, FILM COATED in 1 BOTTLE (63629-2438-1) 2017-04-040000-00-00NoNoCurrent